Calling all clones

WASHINGTON — The Food and Drug Administration on Jan. 15 declared meat and milk from clones of cattle, swine and goats, as well as from the offspring of clones of any species traditionally consumed as food, are as safe to eat as food derived from conventionally bred animals. The F.D.A. concluded there was no food safety reason to prevent food derived from clones of these animal species from entering the marketplace but urged producers and cloning technology providers to continue to observe a voluntary moratorium on introducing such products to allow for a transition during which domestic consumer and international trade partner acceptance is assured.

Because it determined there were no food safety issues involved, the F.D.A. indicated there would be no special labeling or additional measures required for meat and milk derived from clones of cattle, swine and goats, or their progeny. The F.D.A. said should a producer express a desire for voluntary labeling, such as "this product is clone-free," it would be considered on a case-by-case basis to ensure compliance with statutory requirements that labeling be truthful and not misleading.

The F.D.A. cautioned there was insufficient evidence for the agency to reach a similar conclusion on the safety of food from clones of other animal species such as sheep.

In December 2006, the F.D.A. issued a preliminary risk assessment that similarly found meat and milk from clones of the specified species were safe. The report was controversial and drew more than 30,000 comments from the public, many expressing concerns about the technology.

"After reviewing additional data and the public comments in the intervening year since the release of our draft documents on cloning, we conclude that meat and milk from cattle, swine and goat clones are as safe as food we eat every day," said Dr. Stephen F. Sundlof, director of F.D.A.’s Center for Food Safety and Applied Nutrition.

Bruce Knight, undersecretary of agriculture for marketing and regulatory programs, said, "The U.S.D.A. fully supports and agrees with F.D.A.’s final assessment that meat and milk from cattle, swine and goat clones pose no safety concerns, and these products are no different than food from traditionally bred animals."

Mr. Knight said the U.S.D.A. will work with the food industry to ensure a smooth transition into the marketplace for these products. Mr. Knight said the U.S.D.A. also encouraged technology providers to maintain their voluntary moratorium on sending milk and meat from animal clones into the food supply during the transition.

The principal cloning technology providers told the press they would continue to observe the moratorium as requested by the F.D.A. and the U.S.D.A. but stressed it applied only to meat and milk from the clones themselves, not to food derived from their offspring resulting from conventional reproduction.

Jim Greenwood, president and chief executive officer of the Biotechnology Industry Organization, said, "The biotechnology industry looks forward to working with the U.S.D.A. and members of the food value chain to support an orderly transition and introduction of products into the marketplace."

At the same time, several meat processors indicated they would not market products derived from cloned animals. A spokesman of Smithfield Foods, Inc., Smithfield, Va., said the company would monitor further scientific research on the technology and in the meantime was "committed to maintaining our focus on the development and improvement of our meat products through careful selective breeding and genetic research."

Dairy producer organizations also expressed concern. Jerry Kozak, president and chief executive officer of the National Milk Producers Federation, said his members strongly supported continuation of the voluntary moratorium, saying consumer apprehension about cloning must be addressed. Mr. Kozak added, "We also need to make certain the U.S. regulatory status of cloned animals parallels the regulatory process used in our major export markets."

In issuing its risk assessment, the F.D.A. thwarted congressional efforts to delay agency action. Senator Barbara Mikulski of Maryland in December won approval for an amendment to the Senate’s farm bill that would have prevented the F.D.A. from issuing a final risk assessment until two studies were completed, one addressing whether the F.D.A.’s examination of the health risk was adequate and took into consideration all available information and the other on possible economic and trade effects of introducing such products. Separately, Ms. Mikulski was successful in inserting language in the fiscal 2008 omnibus spending bill passed by Congress and signed by President Bush that strongly encouraged the F.D.A. to delay any major decision pending additional studies.

In response to the F.D.A.’s final risk assessment, an angry Ms. Mikulski said, "The F.D.A. has acted recklessly and I am profoundly disappointed in their rush to approve cloned foods … Just because something was created in a lab doesn’t mean we should have to eat it. If we discover a problem with cloned food after it is in our food supply and it’s not labeled, the F.D.A. won’t be able to recall it like they did Vioxx. The food will already be tainted."

Mr. Knight addressed congressional concerns, stating, "In conjunction with the F.D.A., the U.S.D.A. also will implement the report language in the 2008 omnibus appropriations bill suggesting we study domestic agricultural and international trade economic implications of commercialization of milk and meat from animal clones."

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